Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation

NCT ID: NCT04199702

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2024-12-31

Brief Summary

Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy employed for the treatment of atrial fibrillation. The conventional approach for post-procedure care has been for the patient to stay overnight and be discharged the next day. However, the overall incidence of procedure related complications of catheter ablation for atrial fibrillation in high volume centers is low. New technologies have been introduced and improve the safety of the ablation procedure. Discharging patients the same day after ablation is a practice that's currently followed by many centers in the United States and abroad. The investigators' hypothesis is that the currently available advanced technologies allow for the same-day safe discharge of patients after catheter ablation. The investigators propose a prospective single-arm study to evaluate the feasibility and safety of the same-day discharge after AF ablation at MGH. The protocol of same-day discharge will include the use of a commercially available venous closure device, early ambulation, bed-side echocardiogram, and follow-up phone calls at day 1 and 3 post-procedure.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Same day discharge

Group Type: OTHER

Same day discharge

Intervention Type: OTHER

Patients will be discharged the same day they undergo catheter ablation of atrial fibrillation.

Interventions

Same day discharge

Patients will be discharged the same day they undergo catheter ablation of atrial fibrillation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age >18 - Age < 75 yr
• Documentation of atrial fibrillation (AF) or atypical atrial flutter
• All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements

Exclusion Criteria

• Heart failure with reduced ejection fraction less than 40%
• Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
• INR > 4.0 at the time of the procedure
• Mental impairment precluding verbal consent or completing follow up
• Patients with any other significant uncontrolled or unstable medical condition
• Women who are known to be pregnant or have had a positive β-HCG test within 7 days prior to procedure
• Presence of left atrial thrombus
• Patients with prior prostate hypertrophy or bladder surgery
• BMI > 40 or BMI <20
• Patients with h/o symptomatic heart failure
• Patients with severe aortic stenosis (AS) or severe mitral regurgitation (MR)
• Patients who require femoral arterial line for blood pressure monitoring

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Moussa C Mansour

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2019P003413

Identifier Type: -

Identifier Source: org_study_id